Edinburgh Clinical Trials

Trial Planning

The planning of a clinical trial can be complex and ECTU are able to provide support over the lifetime of the study, from the application process through to close down and reporting.

We would strongly recommend seeking advice early in the planning stage as the design, feasibility and costing of a proposal can take some time.


ECTU provides a comprehensive infrastructure reflecting the knowledge and expertise to design, develop and deliver a clinical trial. The key services are:

•    Methodology and statistics

•    Trial management

•    Data management and programming

•    Health economics

•    Patient, carer and public involvement (PCPI) – delivered via  https://www.ed.ac.uk/clinical-research-facility/patient-and-public-involvement 

•    Research management and business planning of awarded trials

•    Quality assurance


What you can expect from ECTU  

•    Help design your clinical trial before funding application and supporting you through the application process.

•    Provide you with a letter of support to the funder if required and once formal ECTU adoption of your clinical trial is confirmed.

•    Work to Sponsor and ECTU SOPs.

•    Develop study-specific working practice documents where required.

•    Host the trial master file (TMF0, or sections of it, ensuring availability and readiness for Inspection if delegated.

•    Advise you at the earliest opportunity of any issues which we consider will have a significant impact on trial progress.

•    Review ECTU budgets closely to ensure quality and value for money.

•    We will provide a table of responsibilities, which will outline tasks ETCU will deliver as part of the application process.  This will impact on resources required to successfully deliver your clinical trial.  Any changes to these tasks must be highlighted and agreed as this may impact on funds and resource use within ECTU.


What we can and cannot do

✔        Work with other institutions and/or organisations acting as the Study Sponsor.  In order to do so they will need to provide a full suite of SOPs and required documents. 

X           We do not support monitoring or pharmacovigilance activities but can provide details of subcontractors should these functions be required.

X          We cannot take responsibility for completing the SoECAT form, but we do expect to review this with you before submission.


Additional Information:  ECTU Studies Within a Trial (SWATs) 

We are keen to embed studies of clinical trial conduct / methodology within our trials.  These are best designed and costed as part of the initial grant application, and there are various options for funding them. Possible ideas for such studies are listed at: http://www.qub.ac.uk/sites/TheNorthernIrelandNetworkforTrialsMethodologyResearch/SWATSWARInformation/Repositories/SWATStore/ 


For enquiries on accessing ECTU support please complete the online new proposal form.


Request For Support: Web Form


Edinburgh Clinical Trials Unit

  • Dr Agnes Tello, Snr Research Development Manager

Contact details



The Usher Institute
University of Edinburgh
Edinburgh BioQuarter
5-7 Little France Road

Post Code
EH16 4UX


Ethical and Regulatory Approval

The Integrated Research Application System (IRAS) is a single system to apply for the permissions and approvals for health and social care / community care research in the UK.

Useful Trial Planning Tools

Find useful trial planning tools here.

Further information:

How to get your trial adopted and access support    
Clinical Support Trial Management Statistical and Health Economics Support
Data Management Governance